Esomeprazole magnesium delayed-release capsules recalled for impurity specification failure
Mylan Institutional Inc. is recalling Esomeprazole Magnesium Delayed-Release Capsules 20 mg due to failed impurity specifications detected during stability testing. 555 cartons of affected lots were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves failed impurity specifications and represents a risk-of-harm product. With no reported illnesses or injuries and per the rubric criteria, this is classified as High severity.
Plain-English summary
Mylan Institutional Inc. (d.b.a. UDL Laboratories) is recalling Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in unit dose blister cards of 6 (10 cards per carton). The product is manufactured for Mylan Pharmaceuticals Inc. and was distributed nationwide within the United States.
The recall was initiated because impurity levels exceeded acceptable specifications during stability testing at the 12-month room temperature time point. Out-of-specification results were detected for any other individual impurity.
The affected lots include: 3112743 (expiration 4/30/2023), 3112582 (expiration 3/31/2023), 3110438, 3111708, and 3111120 (expiration 7/31/2022). A total of 555 cartons were distributed.
The recalled product
- Product
- Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16
- Manufacturer
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Category
- Drug
- Hazard
- impurity-exceedance
- degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #: 3112743
- Exp. Date 4/30/2023
- 3112582
- Exp. Date 3/31/2023
- 3110438
- 3111708
- 3111120
- Exp. Date 7/31/2022
Distribution
Distributed nationwide across the United States.
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